Clinical Trial Associate (FSP)

Role Information

As a Clinical Trial Associate (CTA) within our Functional Service Provider (FSP) division, you will play a vital role in the operational success of our clinical trials. You will provide high-level administrative and operational support, ensuring all trial activities are executed in compliance with ICH-GCP guidelines, Standard Operating Procedures (SOPs), and regulatory requirements. This role offers the unique opportunity to work dedicatedly with a single sponsor, gaining deep experience within their specific therapeutic areas and processes.

Key Responsibilities

1. Study Tracking & Documentation: Maintain and update tracking systems and tools to monitor study progress from start-up through closeout.

2. eTMF Management: Set up and maintain study files and shared spaces; perform routine quality checks on trial-level documents to ensure completeness and accuracy in the Electronic Trial Master File (eTMF).

3. Meeting Coordination: Schedule team meetings, prepare comprehensive agendas, and distribute minutes and follow-up action items.

4. Operational Support: Assist in the development of study management tools, monitoring manuals, and training materials.

5. Supply & Vendor Management: Manage study sample and supply tracking, and support interactions with third-party vendors as needed.

6. Financial Tracking: Assist with basic budget tracking and clinical invoice processing for assigned projects.

Qualifications

1. Education: BS/BA degree in a life science or healthcare field is required.

2. Experience: * Minimum of 1 year of experience supporting clinical operations at a sponsor company, OR

   • Minimum of 2 years of experience in a Clinical Research Organization (CRO) environment.

3. Knowledge: Foundational understanding of the drug development process, ICH-GCP guidelines, and Code of Federal Regulations (CFR).

4. Technical Skills: Proficiency in MS Office Suite (Excel, Word, PowerPoint) and experience with eTMF systems (e.g., Veeva Vault).

5. Attributes: Exceptional attention to detail, strong organizational skills, and the ability to manage multiple tasks under tight deadlines.